The platinum chromium element stent platform: from alloy, to design, to clinical practice

Background-Drug eluting stents with durable polymers may be associated with hypersensitivity, delayed healing, and incomplete endothelialization, which may contribute to late/very late stent thrombosis and the need for prolonged dual antiplatelet therapy. Bioabsorbable polymers may facilitate stent healing, thus enhancing clinical safety. The SYNERGY stent is a thin-strut, platinum chromium metal alloy platform with an ultrathin bioabsorbable Poly(D,L-lactide-co-glycolide) abluminal everolimus-eluting polymer. We performed a multicenter, randomized controlled trial for regulatory approval to determine noninferiority of the SYNERGY stent to the durable polymer PROMUS Element Plus everolimus-eluting stent. Methods and Results-Patients (n=1684) scheduled to undergo percutaneous coronary intervention for non-ST-segmentelevation acute coronary syndrome or stable coronary artery disease were randomized to receive either the SYNERGY stent or the PROMUS Element Plus stent. The primary end point of 12-month target lesion failure was observed in 6.7% of SYNERGY and 6.5% PROMUS Element Plus treated subjects by intention-to-treat (P=0.83 for difference; P=0.0005 for noninferiority), and 6.4% in both the groups by per-protocol analysis (P=0.0003 for noninferiority). Clinically indicated revascularization of the target lesion or definite/probable stent thrombosis were observed in 2.6% versus 1.7% (P=0.21) and 0.4% versus 0.6% (P=0.50) of SYNERGY versus PROMUS Element Plus-treated subjects, respectively. Conclusions-In this randomized trial, the SYNERGY bioabsorbable polymer everolimus-eluting stent was noninferior to the PROMUS Element Plus everolimus-eluting stent with respect to 1-year target lesion failure. These data support the relative safety and efficacy of SYNERGY in a broad range of patients undergoing percutaneous coronary intervention. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01665053.(Circ Cardiovasc Interv. 2015;8:e002372.

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“…SYNERGY has been compared with the durable polymer PROMUS Element EES as described previously 9,10 (Table 1).…”

Section: Device Descriptionmentioning

confidence: 99%

Efficacy and Safety of a Novel Bioabsorbable Polymer-Coated, Everolimus-Eluting Coronary Stent

Kereiakes

Meredith

Windecker

et al. 2015

Circ: Cardiovascular Interventions

228

126

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“…To address these limitations, several novel technologies have been developed, one of them being BMS with an improved stent design. Cobalt-chromium (CoCr) replaced stainless steel, allowing thinner stent struts with the associated advantages of better flexibility and reduced restenosis rates [5,8,9]. In addition, passive stent coating may further reduce restenosis rates [10,11].…”

Section: Introductionmentioning

confidence: 99%

Prospective, multi-center evaluation of a silicon carbide coated cobalt chromium bare metal stent for percutaneous coronary interventions: Two-year results of the ENERGY Registry

Erbel

Eggebrecht

Roguin

et al. 2014

Cardiovascular Revascularization Medicine

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The population of ENERGY reflects real-world conditions with bare metal stents being mainly used in simple lesions. In this setting, percutaneous coronary intervention using a cobalt-chromium thin strut bare metal stent with a passive coating showed very good results up to 24months. (ClinicalTrials.gov:NCT01056120) SUMMARY FOR ANNOTATED TABLE OF CONTENTS: The ENERGY international registry evaluated the safety and benefits of a cobalt-chromium thin strut bare metal stent with passive coating in 1016 patients under real-world conditions until 2years. Results were encouraging with a low composite rate of cardiac death, myocardial infarction and clinically driven target lesion revascularization, even in the pre-defined high risk groups of diabetes, stents ≤2.75mm and acute coronary syndrome.

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“…9,12,14,16 Entre as ligas metálicas atuais destacam-se a de cromo-cobalto e a de platina-cromo. 18,19 Ambas permitem aliar os benefícios de hastes finas, stents mais flexíveis e manutenção da visibilidade.…”

Section: Discussionunclassified

Stents convencionais de aço inoxidável vs. cromo-cobalto: impacto clínico da liga metálica no cenário atual - registro InCor

Ribeiro¹,

Campos²,

Lopes³

et al. 2011

Rev. Bras. Cardiol. Invasiva

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Stainless Steel versus Cobalt-Chromium Bare Metal Stents: Clinical Impact of the Metal Alloy in a "Real World" ScenarioInCor RegistryBackground: Years ago studies demonstrated that the use of cobalt-chromium stents with thinner struts significantly reduced coronary restenosis when compared to conventional stainless steel stents available at the time. Since then, stents with struts < 100 µm and different metal alloys are available for clinical use. The objective of this study was to assess differences in the clinical outcomes of patients undergoing percutaneous coronary intervention (PCI) with thin strut stents and different metal alloys. Methods: Single center registry comparing the results of patients undergoing PCI with stainless steel stents (n = 135) vs. cobalt-chromium bare metal stents (n = 181). The primary endpoint was the occurrence of major adverse cardiac events (MACE), defined by death, acute myocardial infarction (AMI) or target vessel revascularization (TVR) in the late follow-up. Results: Mean patient age was 64 ± 11 years, 32.6% were diabetic and 65.5% had acute coronary syndrome at admission, with no differences for most of the clinical and angiographic characteristics assessed between groups. The use of direct stenting was more frequent in the cobalt-chromium group (30.3% vs. 40.2%; P = 0.04). After a median of 500 days of follow up, there was no statistically significant difference between groups for the occurrence of MACE (15.5% vs. 16.5%; P = 0.6), death (4.6% vs. 6.8%; P = 0.29), AMI (2.7% vs. 4.1%; P = 0.41) or TVR (10.4% vs. 10.1%; P = 0.97). Conclusions: In this real world population, cobaltchromium stents had similar efficacy and safety when compared to stainless steel stents, but with less coronary instrumentation.

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The platinum chromium element stent platform: from alloy, to design, to clinical practice

Cited by 103 publications

References 17 publications

Efficacy and Safety of a Novel Bioabsorbable Polymer-Coated, Everolimus-Eluting Coronary Stent

Efficacy and Safety of a Novel Bioabsorbable Polymer-Coated, Everolimus-Eluting Coronary Stent

Prospective, multi-center evaluation of a silicon carbide coated cobalt chromium bare metal stent for percutaneous coronary interventions: Two-year results of the ENERGY Registry

Stents convencionais de aço inoxidável vs. cromo-cobalto: impacto clínico da liga metálica no cenário atual - registro InCor

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